Topiramate oral liquid suspension and use thereof

a technology of topiramate and oral liquid, which is applied in the directions of dispersed delivery, drug compositions, inorganic non-active ingredients, etc., can solve the problems of serious health threat to people's health and affect their daily lives, and achieve pleasant taste, and suitable stability of suspended active ingredients

Active Publication Date: 2021-03-11
OWP PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011]The composition described herein is an oral liquid suspension that includes a suspending agent, viscosifying agent, anticaking agent, and redispersing agent. Achieving a suitable stability of the suspended active ingredient is achieved in part by modifying the pH of the composition. Achieving a suitable stability of the suspended active ingredient is also achieved in part by controlling the particle sire distribution as well as the water content of the active ingredient. Including a suitable flavoring agent provides a composition that is relatively pleasant tasting. The oral liquid suspension, compared to the solid oral dosage form (e.g., tablets) containing topiramate, is therefore (i) convenient to use, (ii) has a relatively quick onset of action, (iii) can be used with children and the elderly who often have difficulties swallowing, and (iv) the dose can readily be titrated. Additionally, the above is achieved while providing for an oral liquid suspension (v) having a suitable redispersibility, (vi) is relatively stable, (vii) is relatively pleasant tasting, (viii) upon shaking will be substantially devoid of lumps or clumps, even after long storage, (ix) possesses good pourability, (x) has good physical stability properties such as low level of sedimentation (reduced or no caking), (xi) has easy redispersion on agitation, and (xii) provides for dose uniformity during each administration.

Problems solved by technology

Epilepsy is a serious threat to people's health and affects their daily lives.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Formulation

[0349]An oral liquid suspension containing topiramate was formulated from the following substances in the amounts specified.

% W / V (mg / ml)Material / Component2.5topiramate0.1methylparaben0.03sodium benzoate powder0.08saccharin sodium dihydrate powder0.25sodium phosphate dibasic3sorbitol solution 70%2.25propylene glycol5glycerin 99% natural grade1.26PROSOLV ® SMCC 50 (silicifiedmicrocrystalline cellulose)0.18carboxymethylcellulose sodium, medium viscosity(2% aqueous solution at 25° C. is 400-800 cps)0.18xanthan gum79.67purified water5polyethylene glycol 4000.5sucralose0.2cherry flavor (natural and artificial)0.002FD&C red #400.0002FD&C yellow #6TOTAL100.2

example 2

Method of Manufacturing

[0350]The oral liquid suspension containing topiramate of Example 1 was manufactured as follows.

Phase 1 Preparation:

[0351]1. Mix propylene glycol and methylparaben until completely dissolved and homogeneous.

Phase 2 Preparation:

[0352]1. Mix water, sodium carboxymethyl cellulose, xanthan gun!, and PROSOLV® SMCC 50M (microcrystalline cellulose and colloidal silicon dioxide) until completely dissolved and homogeneous.[0353]2. Add sodium benzoate, sodium phosphate dibasic, and sodium saccharin and mix until completely dissolved and homogeneous.[0354]3. Add polyethylene glycol; and mix until completely dissolved and homogeneous.[0355]4. Add sorbitol, 70% solution and mix until completely dissolved and homogeneous.[0356]5. Add topiramate and mix until completely dissolved and homogeneous.

Phase 3 Preparation:

[0357]1. Add Phase 1 into Phase 2 with continuous mixing, until completely dissolved and homogeneous.[0358]2. Add glycerin and mix until completely dissolved and ...

example 3

Packaging

[0362]The oral liquid suspension of Example 1 was manufactured for packaging, shipment, storage, and for use with the following.

ContainerOral DispenserPlastic bottleMeasuring cupGlass bottleMeasuring syringeMeasuring dropper

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PUM

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Abstract

Provided herein is an oral liquid suspension that includes topiramate, as well as methods of medical treatment that include orally administering the oral liquid suspension.

Description

RELATED U.S. APPLICATION DATA[0001]This application is a continuation-in-part (CIP) of patent application Ser. No. 16 / 946,132 filed Jun. 8, 2020 which application claims priority to provisional patent application No. 62 / 858,415 filed on Jun. 7, 2019; the contents of which are incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTION[0002]Epilepsy is a disease of the nervous system which is caused by brain dysfunction due to excessive discharge of the nerve cells in the brain. It is estimated that the incidence rate of epilepsy is from about 0.3% to 0.5% globally. The morbidity rate is from about 5 to 10 people per 1000 people. Epilepsy is a serious threat to people's health and affects their daily lives.[0003]Topiramate is an antiepileptic drug and its chemical structure relates to amino-sulfamate monosaccharide. Topiramate was first developed by Johnson & Johnson Company, Inc. USA. It was marketed under the brand name of Topamax in the UK in 1995. Based on in-vit...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/7048A61K47/10A61K47/14A61K47/12A61K47/36A61K47/38A61K47/02A61K9/10
CPCA61K9/0095A61K31/7048A61K47/10A61K47/14A61K9/0056A61K47/36A61K47/38A61K47/02A61K9/10A61K47/12A61K31/36A61K47/26A61P1/00Y02A50/30
Inventor SUDHAKAR, PAULBOYER, SCOTT
Owner OWP PHARMA INC
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